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Clinical Trials in France / NCT05224323
Recruiting Observational

Avalanche Phenomenon During Airways Opening in Acute Respiratory Distress Syndrome

NCT05224323 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2022-03-01
Last updated
2025-12-24

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Airway pressure, flow, esophageal pressure, ventilation distribution

Airway pressure, flow, esophageal pressure, ventilation distribution: After informed consent, baseline characteristics of patients will be collected. Airway pressure, flow and esophageal pressure will be recorded using high sampling rate and ventilation distribution using electrical impedance tomography will be recorded during the study. The ventilator will be set at a positive end-expiratory pressure of 15 cmH2O during 10 minutes. Then, respiratory rate will be decreased to 8 breaths/min, and positive end-expiratory pressure will be decreased to 5 cmH2O over one breath to measure the recruited volume. Then, three low-flow inflation and deflation pressure-volume curves will be performed before resuming clinical ventilator settings. Patients will be followed until Day 28 after inclusion or ICU discharge. Maneuvers performed are part of the usual care of patients with acute respiratory distress syndrome in our unit.

Study summary

Acute respiratory distress syndrome accounts for 23% of mechanically ventilated patients and is associated with high mortality rate. Although life-saving, mechanical ventilation may worsen lung injury through two main mechanisms: lung overdistension and atelectrauma. Indeed, the cyclic opening and closure of airways during tidal ventilation may cause lung and bronchial injuries as suggested by animal models and autopsy findings. Complete airways closure has recently been described in 40% of patients with acute respiratory distress syndrome, and setting positive end-expiratory pressure above the airway opening pressure may limit atelectrauma. However, animal and mathematical models suggest that above the airway opening pressure, more distal airways open unevenly according to their own opening pressure, resulting in an "avalanche"-like phenomenon during lung inflation. This phenomenon has never been described in humans. A better understanding of the opening of airways in acute respiratory distress syndrome may help to limit ventilation-induced lung injury and to improve outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 * Moderate-to-severe acute respiratory distress syndrome within the first 72 hours after meeting the Berlin definition criteria: * Within 1 week of a known clinical insult or new or worsening respiratory symptoms; * Bilateral opacities (not fully explained by effusions, lobar/lung collapse, or nodules); * Respiratory failure not fully explained by cardiac failure or fluid overload; * PaO2/FiO2 ≤ 200 mmHg with positive end-expiratory pressure ≥ 5 cmH2O. * Absence of spontaneous breathing efforts * Consent to participate to the study from the patient and/or its surrogate Exclusion Criteria: * Pneumothorax * Broncho-pleural fistula * Tracheostomy * Hemodynamic instability * Severe hypoxemia * Suspected of proven intracranial hypertension * Chronic obstructive lung disease * Pacemaker or defibrillator * Decision to withhold of withdraw life-sustaining measures * Under protection

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU Poitiers Poitiers France Recruiting

More Poitiers University Hospital trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05224323 on ClinicalTrials.gov ↗ ← All trials in France